QT PRODACT: Sensitivity and Specificity of the Canine Telemetry Assay for Detecting Drug-Induced QT Interval Prolongation

Author:

Miyazaki Hiroyasu,Watanabe Hiroyuki,Kitayama Tetsuya,Nishida Masahiro,Nishi Yasuhiro,Sekiya Koji,Suganami Hideki,Yamamoto Keiji

Publisher

Japanese Pharmacological Society

Subject

Pharmacology,Molecular Medicine

Reference26 articles.

1. 1 ICH Harmonised Tripartite Guideline, The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals S7B. Recommendation for adoption at step 4 of the ICH process on 12 May 2005 by the ICH Steering Committee. ICH; http://www.ich.org/.

2. 2 ICH Harmonised Tripartite Guideline, Safety Pharmacology Studies for Human Pharmaceuticals S7A. Recommended for adoption at step 4 of the ICH process on 8 November 2000 by the ICH Steering Committee. ICH; http://www.ich.org/.

3. 3 Hanton G, Nahas K, Priou C, Rabemampianina Y, Baneux P. The QT interval in the dog ECG: importance in preclinical toxicology and relationship to heart rate. Toxicol Methods. 2001;11:21–40.

4. 4 Bazzett HC. An analysis of the time-relations of electrocardiograms. Heart. 1920;7:353–370.

5. 5 Fridericia LS. Die systolendauer im electrokardiogramm bei normalen menshen und bei herzkranken. Acta Med Scand. 1920;53:469–486. (in German)

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